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The investigators want to evaluate the effects and safety of ginger in treatment of nonalcoholic fatty liver disease (NAFLD) in patients with type 2 diabetes mellitus (T2DM).
Ginger (Zingiber officinale Roscoe) has been cultivated for medicinal and culinary purposes for at least two millennia. It contains several hundred valuable compounds and new constituents are still being found. Ginger's high antioxidant value has proved highly effective with its ability to scavenge a number of free radicals and protect cell membrane lipids from oxidation in a dose-dependent manner.
In a randomized double-blind placebo-controlled clinical trial, the investigators want to investigate the effects of ginger in treatment of nonalcoholic fatty liver disease (NAFLD) in patients with type 2 diabetes mellitus (T2DM).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ginger | Experimental | Ginger powder capsule 500 mg |
|
| Placebo | Placebo Comparator | Placebo powder capsule |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ginger | Drug | Ginger powder capsule 1000 mg twice daily for 3 months |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in ALT (liver transaminases) level | Change in the concentration of ALT (liver transaminases) | Baseline and 3 months |
| Change in score of fatty liver in fibroscan | Change in score of fatty liver in fibroscan (elastography) | Baseline and 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in AST (liver transaminases) level | Change in the concentration of AST (liver transaminases) | Baseline and 3 months |
| Change in Gama GT (γ-glutamyl transpeptidase) levels | Change in the concentration of Gama GT (γ-glutamyl transpeptidase) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mesbah Shams, M.D. | Endocrine and Metabolism Research Center, Shiraz University of Medical Sciences | Study Chair |
| Majid Nimruzi, M.D. | Research Center for Traditional Medicine, Shiraz University of Medical Sciences | Principal Investigator |
| Kamran Bagheri Lankarani, M.D. | Health policy Research Center, Shiraz University of Medical Sciences | Principal Investigator |
| Parisa-sadaat Ghoreishi, M.D. | Shiraz University of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shahid Motahhari Clinic, Shiraz University of Medical Sciences | Shiraz | Fars | Iran |
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| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
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| ID | Term |
|---|---|
| C000713927 | ginger extract |
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| Placebo |
| Drug |
Placebo powder 2 capsules twice daily for 3 months |
|
| Baseline and 3 months |
| Number of patients with adverse events | Number of patients with adverse events | 4 months |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |